UCI as the Relying IRB

Relying IRB will rely on the review of the Reviewing (external) IRB. The IRB may refuse, on a case-by-case basis, to rely on the review of another IRB.

Single IRB (sIRB) Submission Process Overview

Label
Label
Label
Label
Label
Label
Label

Step 1

Review the UCI HRP Policy #4 & this Website

  • UCI Investigator confirms Relying IRB eligibility criteria 

Step 2

UCI Investigator Pre-Submission

  • Initiate process to obtain other UCI regulatory committee/ institutional approvals (i.e., Radiation Safety Committee (RSC), Conflict of Interest Oversight Committee (COIOC)), as needed
  • Industry Sponsored Clinical Trials:
    • Confirm that the Sponsor/CRO has contracted with the External IRB to provide services for the study
    • Confirm that the Sponsor/CRO will include the UCI IRB fees in the clinical trial budget

Step 3

UCI Investigator Submits a New sIRB Application

Step 4

UCI IRB Agrees to Rely 

  • UCI local context and consent form language confirmed
  • Clearance Notice Issued 

Step 5

UCI Investigator/Sponsor Submits to External IRB 

  • External IRB reviews UCI documentation

Step 6

External IRB Agrees to serve as Reviewing IRB

  • sIRB Agreement signed by Reviewing IRB or Approval Letter documenting UCI as a Relying Site
  • Release of UCI specific approved documents

Step 7

UCI Releases the Initial Reliance Approval & Study Documents

Eligibility: UCI as the Relying IRB

Eligibility: UCI as the Relying IRB

The UCI IRB complies with the following single IRB (sIRB) requirements:

EntityRegulations / PolicyExceptions
Department of Human Health Services (DHHS) / Signatories of the 2018 Common Rule2018 Revised Common Rule
45 CFR 46.114 Cooperative Research
Any institution located in the United States that is engaged in cooperative (non-Exempt) research must rely upon approval by a single IRB (sIRB) for that portion of the research that is conducted in the United States.

The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.		§ 46.114(b)(2)
The following research is not subject to this provision:

(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or

(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
National Institutes of Health (NIH)NOT-OD-16-094 (policy webpage)
An NIH-funded study being conducted at more than one U.S. site involving non-exempt human subjects research may be subject to the NIH Single IRB (sIRB) policy and/or § 46.114.

As of January 20, 2020, studies subject to § 46.114 must use a single IRB as required by the terms and conditions of award. This includes studies that are not subject to the NIH sIRB policy – such as domestic, multi-site, career development (K), fellowship (F) awards, and Other Transaction (OT) awards.		Exceptions to Use of sIRB Are Rare
NIH sIRB Policy exception requests not based on a federal/state/Tribal law, regulation, or policy require the review and approval of the NIH Office of the Director (OD). NIH will consider exception requests for studies subject to the NIH sIRB Policy if they are NOT also subject to § 46.114.

For questions or requests for an exception to the NIH sIRB Policy applicants/recipients should consult with their Program Officials (POs), and offerors with their Contracting Officials (COs).

When not otherwise federally mandated, UCI will consider relying on an external (non-UCI) IRB for review.

 

In general, UCI may rely upon the IRB of another institution provided one of the following is true:

  1. The IRB is the IRB of an AAHRPP accredited organization, or the organization is actively seeking AAHRPP accreditation.
  2. The IRB has current certification from the Consortium for Applied Research Ethics Quality (CARE-Q).
  3. The UCI Investigator is a collaborator on human research primarily conducted at another institution and the UCI investigator’s role does not include interaction or intervention with subjects.
  4. UCI is engaged in human research solely because UCI is the prime awardee. UCI investigators will not interact or intervene with subjects or collect or possess private identifiable information about subjects, nor obtain informed consent.
  5. Unless it is an IRB Organization, the institution must maintain an OHRP-approved Federalwide Assurance (“FWA”), regardless of whether it engages in federally funded human subjects research that is subject to the Federal Policy for the Protection of Human Subjects (“Federal Policy”).

For more information, refer to HRP Policy # 4 and the Checklist - Request to Rely on a Non-UCI IRB.

Eligibility: UCI Relying on Advarra / WIRB Copernicus Group, Inc. (WCG) IRB

 

The chart below reflects which studies are eligible to cede to Advarra / WCG IRB, and which ones are not eligible.

IMPORTANT! To maintain efficiencies and provide consistency for the IRB, the HRP, our Research Faculty, and Research Coordinators, no exceptions will be made. If the study sponsor has questions, please cite this webpage.

Question mark icon

Need Help Assessing sIRB Eligibility?

Submit a 'Relying IRB Screener'

Download a Quick Start Guide

UCI as the Relying Privacy Board

UCI as the Relying Privacy Board

 

When the UCI is the Relying IRB, it does NOT rely on the External HIPAA Privacy Board. Rather, the UCI IRB continues to serve as the HIPAA Privacy Board. Exceptions may be considered.

The UCI IRB determines whether participants should sign an "Authorization" or if a Waiver of HIPAA Authorization may be granted. Each institution will retain their own privacy reporting responsibilities should a breach of privacy occur.

External sIRB Agreements

External sIRB Agreements

External Entity/IRBsIRB Agreement Description
Advarra Institutional Review Board (IRB)Advarra is an independent IRB that provides services for academic and non-academic institutions.

UC has a Master Service Agreement with Advarra to serve as the IRB of record for eligible clinical trials. For these trials, the industry sponsor’s protocol has already received IRB approval from Advarra.
Institutional Authorization Agreement (IAA)An IAA is a formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying Institution.

When a non-UCI entity is an institution that does not have their own IRB and they do not participate with SMART IRB, an IAA may be utilized.
National Cancer Institute (NCI) Central IRB (CIRB)The Adult NCI CIRB reviews Cooperative Group trials from the ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC, NSABP, RTOG, and SWOG, as well as any other studies opened in the Cancer Trials Support Unit (CTSU).

    • Early Phase Emphasis (EPE) – Phase 0, 1 or 2 studies
    • Late Phase Emphasis (LPE) – Phase 3 studies

UCI has established a formal agreement with the Adult NCI CIRB, investigators who wish to participate in these Cooperative Group trials can take advantage of this single IRB review model.
SMART IRBSMART IRB provides a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, supporting and encouraging collaboration and harmonization across the nation.

The following reliance agreements will be processed utilizing the SMART IRB agreement:

    • Children's Hospital of Orange County (CHOC) - MemorialCare Health System (MHS) - UCI IRB (CMU IRB Reliance)
    • NEALS - Northeast ALS Consortium
    • NeuroNEXT
    • StrokeNet
    • UC IRB Reliance
    • Other Single Institutional Agreements (e.g., Fountain Valley, Kaiser)
WIRB Copernicus Group (WCG) IRBWCG is an independent IRB located in Olympia, Washington that provides services for academic and non-academic institutions.

UC has a Master Service Agreement with WCG IRB to serve as the IRB of record for eligible clinical trials. For these trials, the industry sponsor’s protocol has already received approval from WCG IRB.

UCI IRB Submission Requirements

UCI Relying Submission Requirements

KRP User Guide

The following requirements will need to be addressed via a new reliance submission in Kuali Research Protocols (KRP):

1.    Submit either a 'Relying IRB Screener' or 'Request to Rely on a Non-UCI IRB Review'

Relying Irb Submission

Type of Submission
When to Submit
Relying IRB Screener
Help is needed to assess sIRB eligibility for a specific study
An investigator has a Disclosable Conflict of Interest
Advarra / WCG study involving any of the following:
*Research on investigational devices
*Research including true placebo
*Phase 1
*Phase 2a
Request to Rely on a non-UCI IRB's Review
Studies are Federally funded (e.g., NIH, NCI, NSF, etc)
Eligibility is aligned with HRP Policy #4

2. Attach the following documents (as applicable):

    • IRB Approval Letter, with active approval date
    • Protocol (when a Master Protocol is not available)
    • Questionnaires/surveys/measures, etc.
    • Sponsor Study Documents:
      • Master Protocol
      • Investigator’s Brochure
      • Documentation from the Sponsor/CRO confirming that:
        • the External IRB is providing IRB services for the study and
        • the Sponsor/CRO will cover IRB review fees
    • UCI Specific Documents:
      • UCI Site Recruitment Materials
      • Draft of External IRB Consent that Includes UCI Template Language
      • UCI HIPAA Research Authorization Form
      • FDA Documentation
    • Evidence of UCI Ancillary Review:
      • Conflict of Interest (COI) Management Plan
      • Radiation Safety Committee (RSC)
      • Institutional Biosafety Committee (IBC)

3.  For SMART IRB or IAA, attach the External sIRB agreement

External IRB Submission Requirements

External IRB Submission Requirements

Prior to initiating any request for an sIRB process, UCI Investigators should review the External IRB's policy/website for reliance/cooperative research and touch base with the sIRB contact at the IRB.

All sIRB applications must address UCI Relying Submission Requirements.

Post-Rely Responsibilities

Post-Rely Responsibilities

TransactionSubmit to External IRB of RecordSubmit to UCI IRB
AmendmentsAccording to External IRB PolicyUCI Specific Changes: once approved by the External IRB, submit a UCI amendment request for the following local context revisions:

1. Adding new version of an approved consent form

2. Any change in the informed consent process (e.g., adding short form consent)

3. Adding translated HIPAA Forms or non-English speaking subjects as a new study population Note: Do not submit translated consent forms

4. Any change in Protected Health Information (PHI)

5. Any change in research site

6. Any change in a research team member’s disclosable financial interests

7. Adding new or revised recruitment materials

8. Change in Lead Researcher

9. Adding or removing Co-Researchers or Research Personnel (when adding individuals UCI IRB approval must be provided prior to the individual engaging in research activities)
RenewalsProgress Report of Research Activities at UCI1. Renewal Letter Approval from the External IRB of Record

2. Routine monitoring reports, as applicable
Reportable EventsAccording to External IRB Policy1. External IRB’s Potential Unanticipated Problem or Noncompliance Form

2. Serious and/or Continuing Noncompliance that occurred at the UCI site

3. Unanticipated Problem that occurred at the UCI site

4. Notification of a hold or a suspension by the FDA, a sponsor, or a DSMB possibly related to risk to human subjects
Advarra: Reporting Requirements
Advarra: SAE Reporting Guidelines
WCG: Reporting Requirements
WCG: Reportable Info Form
Audits By External EntitiesAccording to External IRB Policy1. Notify UCI IRB and Internal Audit Services in advance of any audit or non-routine monitoring of study records to be conducted by an external entity (e.g., FDA, OHRP, study sponsor, CRO). The IRB and/or Internal Audit Services may wish to send a representative to observe proceedings including the "exit interview."

2. Any audit or non-routine monitoring written reports must be submitted to UCI, Routine monitoring findings by study sponsor or CRO must also be submitted to UCI IRB for their review and records.

3. Reports that include significant findings (potential Unanticipated Problem, Serious or Continuing Noncompliance) must be reported.
Study ClosureAccording to External IRB PolicyExternal IRB’s study closure report

UCI Relying FAQs

UCI Relying FAQs